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Last Updated: April 20, 2025

Details for New Drug Application (NDA): 040041

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NDA 040041 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms Inc, Trupharma, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-five NDAs. It is available from thirteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There are twelve drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 040041

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Taro
Ingredient:	fluocinolone acetonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 040041

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.025%
Approval Date:	Sep 15, 1994	TE:	AT	RLD:	No

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